| Device Classification Name |
accelerator, linear, medical |
|||
|---|---|---|---|---|
| 510(k) Number | K111106 | |||
| Device Name | TRUEBEAM | |||
| Applicant |
|
|||
| Applicant Contact | vy tran | |||
| Correspondent |
|
|||
| Correspodent Contact | vy tran | |||
| Regulation Number | 892.5050 | |||
| Classification Product Code |
|
|||
| Date Received | 04/20/2011 | |||
| Decision Date | 08/18/2011 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Radiology |
|||
| 510k Review Panel |
Radiology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |
|||
| Recalls | CDRH Recalls |